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Mindfulness in Old Adults With Subjective Cognitive Complaints

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ClinicalTrials.gov Identifier: NCT03195985
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of Westminster
Imperial College London
Information provided by (Responsible Party):
Marcela P. Vizcaychipi, Chelsea and Westminster NHS Foundation Trust

Brief Summary:

The study will focus on measuring stress, rumination and cognitive function across three time points in old adults with subjective cognitive complaints via a 4-week short mindfulness intervention, as compare to an active control condition (psycho-education course "ge Well").

This is a pilot study.


Condition or disease Intervention/treatment Phase
Subjective Cognitive Complaints Mindfulness Other: Mindfulness-based intervention Other: Age Well psycho-education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Managing Stress and Cognitive Difficulties With a Short Mindfulness-based Intervention in Old Adults With Subjective Cognitive Complaints
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : February 1, 2018

Arm Intervention/treatment
Experimental: Mindfulness-based Intervention
Mindfulness intervention of 4 weeks
Other: Mindfulness-based intervention
A shortened, 4 week mindfulness intervention course based on the original 8 week mindfulness-based stress reduction course by Jon Kabat-Zinn

Active Comparator: "Age Well" psycho-education course
4-week active control condition
Other: Age Well psycho-education
4-week active control condition aimed at psycho-education regarding healthy ageing




Primary Outcome Measures :
  1. Changes in cortisol levels between the two MCI groups over time [ Time Frame: One month ]
    assessed by collecting hair from the vertex posterior for stress hormone analysis


Secondary Outcome Measures :
  1. Changes in anxiety over time [ Time Frame: One month ]
    Beck's Anxiety Inventory

  2. Changes in verbal learning and memory over time [ Time Frame: One month ]
    Mini-Mental State Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All willing and consenting patients over the age of 65
  • Patients who have been admitted to the hospital and who have been formally diagnosed with MCI at the Memory Clinic
  • Patients with hair at the posterior vertex
  • Patients with fluent English
  • Patients who can commit to the entire length of the study
  • Patients with interest in mindfulness

Exclusion criteria:

  • Being under 65 years of age
  • Presence of any psychiatric disorders,
  • Presence of myopathy
  • Presence of atherosclerosis
  • Use of steroids
  • Having undergone chemotherapy
  • heart disorder
  • dementia
  • head injury
  • advanced neurodegenerative disease
  • any patient having had dyed their hair less than one week prior to the first cortisol sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195985


Locations
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United Kingdom
Chelsea and Westminster Hospital NHS Trust
London, United Kingdom, sw10 9nh
The Magill Department of Anaesthesia, Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
University of Westminster
Imperial College London
Investigators
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Principal Investigator: Trudi Edginton, PhD Chelsea & Westminster Hospital, London UK

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Responsible Party: Marcela P. Vizcaychipi, Consultant in Anaesthesia and Intensive Care, Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03195985     History of Changes
Other Study ID Numbers: C&W1234
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No